510(k) Report

510(k) · Cleared

Recalled · 2006

4D Integrated Treatment Console

K050479510(k) SpecialCleared Mar 24, 200528-day reviewClass II21 CFR 892.5050Recalls 2

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

Varian Medical Systems · IYE Accelerator, Linear, Medical

Cleared on Mar 24, 2005 as substantially equivalent to K001643 (Varian Medical Systems, Inc., 2000) after a 28-day review. Its family tree reaches back 1 generation to 2000. 72 later devices descend from it. It has been recalled 2 times.

Decided
Mar 24, 2005
Review
28 days
Class
Class II
Product code
IYE
Recalls
2
Predicates
1

Its longest line of descent runs back 1 generation to K001643 (2000). 72 later devices descend from it, 3 citing it directly.

Descendants, by year cleared 2010: 1 descendant cleared2008: 1 descendant cleared2009: 2 descendants cleared2011: 3 descendants cleared2014: 4 descendants cleared2012: 3 descendants cleared2015: 4 descendants cleared2021: 9 descendants cleared2017: 7 descendants cleared2018: 5 descendants cleared2013: 2 descendants cleared2019: 5 descendants cleared2016: 2 descendants cleared2022: 4 descendants cleared2026: 5 descendants cleared2023: 9 descendants cleared2025: 2 descendants cleared2020: 2 descendants cleared2024: 2 descendants clearedK001643 · Varis 1.4G · Varian Medical Systems, Inc. · 2000 · recalled200020052010201520202025
Descendants, by generation 1 generation forward: 3 descendants2 generations forward: 6 descendants3 generations forward: 5 descendants4 generations forward: 4 descendants5 generations forward: 6 descendants6 generations forward: 10 descendants7 generations forward: 8 descendants8 generations forward: 7 descendants9 generations forward: 6 descendants10 generations forward: 5 descendants11 generations forward: 4 descendants12 generations forward: 4 descendants13 generations forward: 3 descendants14 generations forward: 1 descendant K001643 · Varis 1.4G · Varian Medical Systems, Inc. · 2000 · recalled0+5+10
  1. Root · 1 generation backK001643 Varis 1.4GVarian Medical Systems, Inc. · 2000 · Recalled
  2. This deviceK050479 4D Integrated Treatment ConsoleVarian Medical Systems · 2005
  3. Descendant · cites it directly · 69 of its ownK081036 4D Integrated Treatment Console with Patient Accessory Verification…Varian Medical Systems, Inc. · 2008 · Recalled
  4. Descendant · 2 generations on · 61 of its ownK092871 Trilogy MXVarian Medical Systems, Inc. · 2009 · Recalled
  5. Descendant · 3 generations on · 43 of its ownK111106 TruebeamVarian Medical Systems, Inc. · 2011 · Recalled
  6. Descendant · 4 generations on · 37 of its ownK123291 TruebeamVarian Medical Systems, Inc. · 2012
  7. Descendant · 4 generations on · 36 of its ownK123808 AgilityElekta, Ltd. · 2013 · Recalled

Showing 5 of 72 descendants. See all descendants

Descendants cleared per year

2008: 12009: 22010: 12011: 32012: 32013: 22014: 42015: 42016: 22017: 72018: 52019: 52020: 22021: 92022: 42023: 92024: 22025: 22026: 5
2008high 9 (2021) · low 1 (2008)2026

Most influential descendants

Showing 5 of 72 · See all
  • K0810364D Integrated Treatment Console with Patient Accessory Verification System (Pavs)Varian Medical Systems, Inc. · 2008 · cites it directly69descendants
  • K092871Trilogy MXVarian Medical Systems, Inc. · 2009 · 2 generations on61descendants
  • K111106TruebeamVarian Medical Systems, Inc. · 2011 · 3 generations on43descendants
  • K123291TruebeamVarian Medical Systems, Inc. · 2012 · 4 generations on37descendants
  • K123808AgilityElekta, Ltd. · 2013 · 4 generations on36descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−1K001643Varis 1.4GVarian Medical Systems, Inc.20008
0 (this device)K0504794D Integrated Treatment ConsoleVarian Medical Systems2005—
+1K0810364D Integrated Treatment Console with Patient Accessory Verification System…Varian Medical Systems, Inc.20083
+2K092871Trilogy MXVarian Medical Systems, Inc.20095
+3K111106TruebeamVarian Medical Systems, Inc.20115
+4K123291TruebeamVarian Medical Systems, Inc.2012—
+4K123808AgilityElekta, Ltd.20132

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200810
200920
201010
201130
201230
201320
201440
201540
201620
201770
201850
201950
202020
202190
202240
202390
202420
202520
202650
FIG. 1 — Lineage of K050479, 2000–2026Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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Notable FDA decisions, review times and new Class I recalls. See an issue.

Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.

Planning a device in IYE? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.

Top candidate predicates for a new IYE device

  1. #1 K252977 Halcyon, Ethos Radiotherapy System (5.0)score 18.8 · 18 generations · no Class I recall
  2. #2 Held for the reportin the report
  3. #3 Held for the reportin the report
Get a 510(k) Report

What was it cleared against? (1)

Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.

TypeNumberDeviceApplicantDecidedRecalls
*K001643Varis 1.4G
Summary page 1
…I Product Code: 90 iYE 3. Predicate Devices to claim substantial equivalence: a. Varian Medical Systems' Varis l.4g (K001643) 4. Device Description: The 4D Integrated Treatment Console provides the user with: * a treatment verification…
Varian Medical Systems, Inc.20008

Also cleared against K001643: 1 other device →

What descends from it? (72)

See all 72

3 later devices cite it directly; ranked here by how many devices descend from each in turn.

NumberDeviceApplicantDecidedDescendants
K0810364D Integrated Treatment Console with Patient Accessory Verification System (Pavs)Varian Medical Systems, Inc.200869
K0911324D Integrated Treatment ConsoleVarian Medical Systems20095
K093967Varian TreatmentVarian Medical Systems, Inc.20101

Has anything in its family been recalled? (0 Class I)

Recalls of this device

DateClassRecallRoot causeReason
Sep 21, 2006Not classifiedZ-0304-2007Software designSelecting an empty space next to the ''Override'' or ''Acquire Actual'' buttons may result in mistreatment to the patient.
Sep 20, 2005Not classifiedZ-1375-06Software designA software anomaly may occur which can lead to patient treatment with the wrong field. The anomaly is reported only to occur when this software version (6.6.5022) is used with Elekta or Siemens linear accelerators .

No ancestor or descendant has a Class I recall.

What does this lineage say?

  • Its one ancestor has a recall.
  • Of its descendants, K081036 (Varian Medical Systems, Inc., 2008) has gone furthest, with 69 descendants of its own.
  • 1 other device also cites its predicate K001643.

How does its category compare?

All IYE devices

IYE Accelerator, Linear, Medical: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · IYE

12in 2025

2007: 232008: 142009: 202010: 232011: 112012: 282013: 182014: 202015: 202016: 212017: 232018: 212019: 192020: 202021: 192022: 122023: 182024: 92025: 122026 (partial year): 14
2007high 28 (2012) · low 9 (2024)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · IYE

170in 2025

2007: 44 days median2008: 69 days median2009: 63 days median2010: 74 days median2011: 94 days median2012: 106 days median2013: 88 days median2014: 100 days median2015: 108 days median2016: 97 days median2017: 94 days median2018: 58 days median2019: 83 days median2020: 67 days median2021: 86 days median2022: 172 days median2023: 129 days median2024: 239 days median2025: 170 days median2026 (partial year): 120 days median
2007high 239 (2024) · low 44 (2007)2026

Receipt to decision; years with fewer than 3 clearances left blank.

Recalls per year · IYE

1in 2025

2007: 782008: 492009: 222010: 272011: 732012: 202013: 112014: 142015: 82016: 72017: 72018: 72019: 22020: 42021: 52022: 32023: 72024: 12025: 12026 (partial year): 4
2007high 78 (2007) · low 1 (2024)2026

Class I (0 since 2007) Class II/III not classified

Adverse event reports per year · IYE

101in 2025

2007: 1552008: 1142009: 1742010: 2462011: 2802012: 1282013: 962014: 1242015: 1002016: 972017: 1252018: 852019: 912020: 742021: 682022: 662023: 1282024: 812025: 101
2007high 280 (2011) · low 66 (2022)2025

MAUDE reports naming product code IYE, not matched to any one device; reports are not rates.

View these four charts as a table
YearDecisionsMedian 510(k) review, daysRecalls (Class I)MAUDE reports
2007234478155
2008146949114
2009206322174
2010237427246
2011119473280
20122810620128
201318881196
20142010014124
2015201088100
20162197797
201723947125
20182158785
20191983291
20202067474
20211986568
202212172366
2023181297128
20249239181
2025121701101
2026141204—

What is it indicated for?

The 4D Integrated Treatment Console is designed to assist the operator of a radiation therapy device in providing accurate treatment set-ups for each patient by monitoring set up parameters and preventing the radiation therapy device from commencing irradiation while any parameter is out of conformance with the treatment plan.

Indications for use as stated in the FDA summary.

Also cleared against K001643

1 other device cites the same predicate.

  • K042956VisionVarian Medical Systems, Inc. · 2005

More from Varian Medical Systems

34 FDA decisions under this applicant name. See the company

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  • K250289Intracavitary/Interstitial SystemVarian Medical Systems · 2025

Recent decisions in IYE

The IYE category page

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  • K261718EZFluence (RADEZ V2)Radformation, Inc. · 2026
  • K260733MRIA Radiation Therapy Information System (MRIA)Manteia Technologies Co., Ltd. · 2026
  • K261856Halcyon, Ethos Radiotherapy System (5.0)Varian Medical Systems, Inc. · 2026
  • K252937ThinkQA 3Dosisoft SA · 2026

https://510kreport.com/device/K050479 · printed Nov 6, 2026

Cite this page

510(k) Report. “K050479: 4D Integrated Treatment Console.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K050479

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Record history
  • FDA decision record loaded May 2, 2026
  • Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
  • Lineage and recalls computed Nov 3, 2026
  • Page last updated Nov 3, 2026